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ROBOtic Care of Post-stroke Pain.

NCT05288270 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2022-03-21

No results posted yet for this study

Summary

In agreement to the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommendations that support the importance of physical functioning as core outcome for pain this randomized, double-blind, controlled clinical trial will be the pilot forming the rational basis for the assessment of the efficacy in the use of Robotic rehabilitation system to prevent chronic post stroke pain development. In fact, according to working hypothesis, proprioceptive inputs with high-intensive bilateral movement training of the hemiplegic arm can improve recovery and plasticity, thus preventing chronic post-stroke pain from occurring within the 3-6 months following stroke.

Conditions

Interventions

DEVICE

Aramis

ARAMIS is composed of two computer-controlled, symmetric and interacting exoskeletons able to compensate the inadequate strength and accuracy of the paretic arm movements, of which it measures residual motor function, and the effect of gravity during rehabilitation. It acts through motion capture of the movements of the unaffected arm. In so doing, the patient is able to replicate the movements of the healthy arm with the paretic arm in synchronous, asynchronous or active-assisted manner. The robot-assisted neurorehabilitation using ARAMIS consists in 60-min sessions for 8 weeks,structured as follows: * 1 to 4 weeks: asynchronous exercises of repletion by the paretic arm of basic exercises 20 times for a total of 200 repetitions per session; * 5 to 8 weeks: replaced by synchronous exercises (100/session) with active-assisted modality.

OTHER

Conventional therapy

The control group will receive conventional rehabilitation consisting in passive mobilization of upper and lower limbs, coordination respiratory exercises, cardiovascular conditioning in the setting posture, conditioning in the upright posture, exercises for the trunk control.

Sponsors & Collaborators

  • S.Anna Rehabilitation Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2022-07-30
Completion
2023-07-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05288270 on ClinicalTrials.gov